22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination (EUSFNTA)

Catholic University of the Sacred Heart

Status: Completed

Conditions: Abdominal Neoplasms

Treatments: Other: Fine Needle Tissue Acquisition

Study type: Interventional

Funder types: Other

Identifiers

NCT04032951

10012/14

Details and patient eligibility

About

To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout the GI tract.

Full description

The use of 22 gauge needle to gather tissue samples under EUS guidance has not been associated with an increased risk, and no major complications have been described so far both for the 22 gauge Procore needle and for standard 22 gauge.20, 21 Potential benefits of this new needle are the possibility of increasing the chance of retrieving tissue specimens for histological examination, with the possibility of increasing the diagnostic accuracy of the procedure saving the need and the cost deriving from on-site cytopathology examination. This may reduce the need to repeat EUS procedures or other more invasive sampling procedures, including surgery.

Enrollment: 100 patients

Sex: All

Ages: 10 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than 18 and less than 80.
• Presence of a solid lesion within or adjacent of the gastrointestinal tract. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
• Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
• Informed consent is obtained

Exclusion criteria

• Previous biopsy of the lesion with diagnosis of malignancy
• Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
• They are unable to understand and/or read the consent form.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Adominal neoplasms patients

Experimental group

Description:

Patients in whom EUS-FNTA is performed with a novel type of biopsy neede.

Treatment:

Other: Fine Needle Tissue Acquisition